Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer

Detailed Description

STUDY PLAN

1. Only the principal investigator, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health Insurance Portability and Accountability Act ) and guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process are strictly guarded.
2. Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.

3. The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality of Life Questionnaire) forms will be completed by patients at the following time point:

   1. Within 3 weeks prior to start of radiotherapy
   2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
   3. Approximately one month after completion of radiotherapy during a follow-up visit
4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse or other healthcare provider will be available to help the patient with any questions regarding the QOL forms.
5. The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: d. Within 3 weeks prior to start of radiotherapy e. Once weekly during radiotherapy f. Approximately one month after completion of radiotherapy during a follow-up visit.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males or females greater than or equal to 18 years of age with a working diagnosis of rectal cancer.

Description

Inclusion Criteria:

• All of the following questions must be answered "yes" for a patient to be eligible for this protocol.

  1. Is there a working diagnosis of rectal cancer? YES NO
  2. Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
  3. Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
  4. Is the patient ≥ 18 years of age? YES NO
  5. Can the patient give informed consent? YES NO

Exclusion Criteria:

• All of the following questions must be answered "no" for a patient to be eligible for this protocol.

  1. Has there been prior radiation to the pelvis? YES NO
  2. Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QoL)	Assessment of Quality of Life of Patients post standard of care radiation therapy	1 year

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Joseph Herman, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 20, 2006
• First Submitted That Met QC Criteria: December 20, 2006
• First Posted (Estimate): December 21, 2006

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Chemoradiation; Rectal Cancer; Rectal Cancer receiving chemoradiation.
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: J06109; NA_00004324 (Other Identifier: JHM IRB)